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DelMar Pharmaceuticals Announces First Quarter Fiscal Year 2017 Financial Results and Corporate Update
Thursday, December 1, 2016Company Profile | Follow Company
The Company also highlights recent corporate and clinical achievements and provides an overview of expected near-term milestones.
Vancouver, BC, December 1, 2016--(T-Net)--DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced its financial results for the quarter ending September 30, 2016, the first quarter of the Company's 2017 fiscal year.
"Looking back, 2016 has been a transformational year for our Company," stated Jeffrey Bacha, DelMar's Chairman and chief executive officer. Our goals this year included listing our company's shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications."
RECENT CORPORATE HIGHLIGHTS
"We were very pleased with the outcome of our End-of-Phase II meeting and the guidance provided by the FDA," said Mr. Bacha. "The DelMar clinical team and our advisors have been developing a Phase III study protocol that would provide strong statistical power, enroll fewer than 200 patients, and is designed to reach its final endpoint in two years or less. We plan to submit the protocol to the FDA in the coming weeks, and subject to the FDA's continued guidance and availability of funding, anticipate initiating a registration-directed Phase III study as soon as practicable."
DelMar also confirmed the accomplishment of critical steps toward initiating new clinical trials designed to position VAL-083 as an alternative to temozolomide in newly diagnosed GBM for patients whose tumors exhibit a high expression of MGMT, the DNA repair enzyme linked to failure of standard front-line chemotherapy and poor patient outcomes:
"Importantly, these two new Phase II trials are largely supported through our collaborators, so their initiation will not materially impact our near-term cash expenditures," stated Mr. Bacha. "Our current working capital will support DelMar's operations for at least the next twelve months and, while our planned Phase III clinical trial will require additional financing, we have the opportunity to expand our clinical research efforts in GBM and to continue advancing our research into new indications without an immediate need to raise additional funds."
EXPECTED NEAR-TERM MILESTONES
SUMMARY OF FINANCIAL RESULTS FOR THE FIRST QUARTER OF FISCAL YEAR 2017 ENDED SEPTEMBER 30, 2016
For the three months ended September 30, 2016 the Company reported a net loss of $2,290,339, or a net loss per share of $0.23, compared to a net loss of $1,621,388, or a net loss per share of $0.15 for the three months ended September 30, 2015.
FINANCIAL SUMMARY
The following represents selected financial information as of September 30, 2016. The Company's financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar's consolidated financial statements and management's discussion and analysis ("MD&A"), as filed.
DelMar's financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the company's website at: http://ir.delmarpharma.com/all-sec-filings.
Selected Balance Sheet Data
September 30, 2016 $ |
June 30, 2016 $ |
|||||||
Cash and cash equivalents |
4,799,033 |
6,157,264 |
||||||
Working capital |
4,532,456 |
5,692,336 |
||||||
Total assets |
5,046,887 |
6,355,799 |
||||||
Derivative liability |
590,345 |
693,700 |
||||||
Total stockholders' equity |
3,974,270 |
4,858,778 |
Selected Statement of Operations Data
For the Three Months Ended:
September 30, |
September 30, |
|||||
2016 |
2015 |
|||||
$ |
$ |
|||||
Research and development |
732,729 |
603,845 |
||||
General and administrative |
1,316,639 |
474,025 |
||||
Change in fair value of derivative liability |
225,688 |
539,446 |
||||
Change in fair value of derivative liability due to change in warrant terms |
- |
21,565 |
||||
Foreign exchange loss (gain) |
15,324 |
(17,473) |
||||
Interest income |
(41) |
(20) |
||||
Net and comprehensive loss |
2,290,339 |
1,621,388 |
||||
Computation of basic loss per share |
||||||
Net and comprehensive loss |
2,290,339 |
1,621,388 |
||||
Series B Preferred stock dividend |
307,298 |
- |
||||
Net and comprehensive loss available to common stockholders |
2,597,637 |
1,621,388 |
||||
Basic weighted average number of shares outstanding |
11,301,989 |
10,620,469 |
||||
Basic loss per share |
0.23 |
0.15 |
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.
The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology ("ASCO") Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (=20mg/m2) was 8.35 months following Avastin™ (bevacizumab) failure compared to published literature where survival of approximately two to five months has been reported.
DelMar's advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians' choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company's clinical advisors.
In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy.
In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.
The company and its collaborators from the University of Texas MD Anderson Cancer Center recently presented data at the 11th Biennial Ovarian Cancer Research Symposium demonstrating that VAL-083 was able to overcome cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca's PARP inhibitor Olaparib™ against ovarian cancer in vitro.
Further details can be found at http://www.delmarpharma.com/scientific-publications.html.
About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company's lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.
For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including, our current reports on Form 8-K.
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